Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT05837858
Status:
COMPLETED
Last Update Posted:
2023-08-03
First Post:
2023-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Human Metabolic Profile and Gut Microbiota Under Various Dietary Quality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized Crossover Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-01', 'studyFirstSubmitDate': '2023-04-20', 'studyFirstSubmitQcDate': '2023-04-20', 'lastUpdatePostDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in metabolite profiles present in blood plasma and urine before the dietary intervention and in kinetics over 24 hours.', 'timeFrame': 'Baseline and 0-24 hours after intervention food intake', 'description': 'Metabolite profiles analyzed using a non-targeted metabolomics approach and targeted metabolomics approach with a Orbitrap Mass Analyzer. Blood plasma samples collected at time 0 hours, 2 hours, 4 hours, and 24 hours. Urine fractions collected at 0-2 hours, 2-4 hours, 4-6 hours, 6-9 hours, 9-12 hours, 12-24 hours and 24-48 hours. Identification of biomarkers of acute intake of the foods of interest through the comparison of specific metabolomes after single dose of WG food or refined grain food in Chinese population.'}], 'secondaryOutcomes': [{'measure': 'The influence of gut flora on whole grain markers', 'timeFrame': 'after the administration of the test meal', 'description': 'Gut flora abundance and metabolites level correlation analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Food biomarker', 'Whole grain', 'Chinese population'], 'conditions': ['Biomarkers']}, 'descriptionModule': {'briefSummary': "The goal of this food intervention study is to screen/validate the whole grain food intake biomarker in health Chinese's population.", 'detailedDescription': 'Although increased consumption of whole grains (WGs) is associated with improved health outcomes, the dietary intake assessment and health mechanisms for WGs or WG-containing food remain unresolved. In addition, information regarding its consumption and health effects in Chinese people is scarce. Biomarkers of WGs intake would allow a more accurate assessment of its consumption in nutrition studies. The investigators want to perform a crossover study where participants were subjected to a WG-wheat flour or a refine wheat-flour Chinese diet. Using a metabolomics approach, the investigators aimed to identify the WG-specific metabolites present in plasma/urine after consumption WG or WG foods, including new candidate biomarkers of WG intake.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women\n* age 18-40 years\n* BMI 18.5-23.9 kg/m2.\n\nExclusion Criteria:\n\n* pregnancy or breastfeeding\n* vegetarian;\n* smokers;\n* acute and chronic diseases;\n* allergic to wheat;\n* frequent nutrients supplement use;\n* medication use of antibiotics within 1-month;\n* more than 3 kg weight change within 3-month;\n* unwillingness to follow dietary restrictions;'}, 'identificationModule': {'nctId': 'NCT05837858', 'briefTitle': 'The Human Metabolic Profile and Gut Microbiota Under Various Dietary Quality', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'Study on Biomarkers of Whole Grain Dietary Intake in Chinese Population', 'orgStudyIdInfo': {'id': 'xuyajun197673'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'whole grain-wheat flour food, then refined wheat flour food', 'description': 'Participants first received food made by 50 g whole grain wheat flour during breakfast in a fasting state. Standardized meals were provided to the volunteers from the dinner of the day before the intervention day, as well as up to 48 h after the administration of the test food. After a washout period of 5 days, volunteers followed a 2-day restricted diet before the intervention day. Participants then received food made by 50 g refined grain wheat flour in a fasting state.', 'interventionNames': ['Other: whole grain-wheat flour food+standardized meals', 'Other: refined wheat flour food+standardized meals']}, {'type': 'EXPERIMENTAL', 'label': 'refined wheat flour food, then whole grain-wheat flour food', 'description': 'Participants first received food made by 50 g refined grain wheat flour during breakfast in a fasting state. Standardized meals were provided to the volunteers from the dinner of the day before the intervention day, as well as up to 48 h after the administration of the test food. After a washout period of 5 days, volunteers followed a 2-day restricted diet before the intervention day. Participants then received food made by 50 g whole grain wheat flour in a fasting state.', 'interventionNames': ['Other: whole grain-wheat flour food+standardized meals', 'Other: refined wheat flour food+standardized meals']}], 'interventions': [{'name': 'whole grain-wheat flour food+standardized meals', 'type': 'OTHER', 'description': 'whole grain food made by 50 g whole grain wheat flour', 'armGroupLabels': ['refined wheat flour food, then whole grain-wheat flour food', 'whole grain-wheat flour food, then refined wheat flour food']}, {'name': 'refined wheat flour food+standardized meals', 'type': 'OTHER', 'description': 'refined grain food made by 50 g refined wheat flour', 'armGroupLabels': ['refined wheat flour food, then whole grain-wheat flour food', 'whole grain-wheat flour food, then refined wheat flour food']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Department of Nutrition and Food Hygiene, School of Public Health, Peking University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Yunjia yang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University'}, {'name': 'Yalin Zhou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'December 30, 2023', 'ipdSharing': 'YES', 'description': 'Shared IPD that underlie results in a publication', 'accessCriteria': 'In a publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}